(219 days)
Not Found
Unknown
While the device performs "automated analysis" and "processing of ultrasound images," the summary does not explicitly mention the use of AI, ML, or related terms like deep learning or neural networks. The description of the validation studies also lacks details about training or test sets in a way that would strongly suggest an ML approach.
No.
The LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters, and provides Quality Score feedback. It does not exert a therapeutic effect on the patient.
Yes
Brief Explanation: The "Intended Use / Indications for Use" section explicitly states that the platform is "intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease," which aligns directly with the definition of a diagnostic device.
Yes
The device description explicitly states "The LVivo platform is a software system for automated analysis of ultrasound examinations." and the intended use is for "non-invasive processing of ultrasound images". There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: The core function of an IVD is to examine biological specimens (like blood, urine, tissue, etc.) to provide information about a patient's health.
- This device analyzes images: The LVivo platform processes ultrasound images. It does not interact with or analyze biological samples from the patient.
- Intended Use focuses on image processing: The intended use clearly states "non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters". This reinforces that the device works with image data, not biological samples.
Therefore, while it is a medical device used for diagnosis and assessment, it falls under the category of medical image analysis software rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
L Vivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.
Product codes
QIH
Device Description
The LVivo platform is a software system for automated analysis of ultrasound examinations. Automated analysis of echocardiographic examinations is done using DICOM movies. The LVivo platform supports global and segmental evaluation of the left ventricle (LV) of the heart. The global LV function is evaluated from two of the apical views: four-chamber (4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LV function is done from three apical views 4CH, 2CH and three chamber (3CH) and supports wall motion evaluation and strain. The LVivo platform supports also global and segmental evaluation of the LV from the parasternal Short Axis (SAX) view and the Parasternal Long Axis view (PLAX).
LVivo PLAX extends the current toolbox of the LVivo platform, providing automated calculation of LV size and function parameters from the PLAX view, for cardiac function evaluation as part of the standard echocardiographic assessment in Echo environment and point-of-care. The measurements from the PLAX view add information about the contraction of the LV, its size and wall thickness and can be used for rapid evaluation of the patient's condition in the point-of-care.
In addition to the LV analysis, the cardiology toolbox includes a module for automated evaluation of the Right Ventricular function and the LVivo Seamless. The LVivo platform includes one additional non-cardiac module for the measurement of the bladder volume.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Heart (Left Ventricle, Right Ventricle), Bladder
Indicated Patient Age Range
Age >=18
Intended User / Care Setting
Echo environment and point-of-care.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The clinical validation included a set of 121 patients referred for routine transthoracic echocardiography according to GCP standards. The population was comprised of 60% male, average age of 66.5 +-17. Inclusion criteria: Age >=18. sinus rhythm without multiple premature beats. Patients with LBBB were excluded from the study. 49% had Normal global LV systolic function, 27% had dilated LV, 24% had LVH, 17% had CAD.
An additional dataset, with exams collected from a USA based medical center, was used for LVivo PLAX validation. The data set included 40 patients with similar inclusion\exclusion criteria as described above. The patient population comprised 67.5% (27) male, average age was 60+-14 ranging from 27 to 87 years of age. BMI measurement was available for 95% (38) of patients with an average BMI of 31.6+- 9.1 ranging from 18.3 to 67.
16.67% (6) had normal systolic LV function, 25% (9) had a mildly impaired LV systolic function, 33.3% (12) were moderately impaired and additional 25% (9) were severely impaired. 25% (10) of patients had dilated LV size. 25% (10) have reported to have LV hypertrophy
The LVivo PLAX was applied automatically to the clips from the 40 exams.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A summary of the Performance Evaluation, which was based upon wellestablished test methods, demonstrated conformity to the intended use.
The clinical validation included a set of 121 patients referred for routine transthoracic echocardiography according to GCP standards. A total of 99 exams (82%) were automatically analyzed. The correlation vs average manual measurements of two sonographers was r=0.79, the primary end point was met.
An additional dataset, with exams collected from a USA based medical center, was used for LVivo PLAX validation. The data set included 40 patients. 90% of exams were automatically analyzed. Results acceptance considered bias and limits of agreement (LOA) as well as correlation for the calculated parameters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Specificity and sensitivity using cutoff value of 28% were 85% and 85% respectively.
Results of Additional Dataset (LVivo PLAX vs Sonographers)
- LVIDd: Corr:0.9., Bias:0.3cm, LOA -0.2, 0.9
- LVIDs: Corr:0.95., Bias:0.42cm, LOA -0.25, 1.1
- FS: Corr:0.74*., Bias:-4%, LOA -19.98, 11.96
- IVSD: Corr:0.72., Bias:-0.16cm, LOA -0.47, 0.13
- PWD: Corr: 0.68., Bias:-0095cm, LOA -0.21, 0.4
- LV Mass: Corr:0.94., Bias:9.14gr, LOA -41.6, 59.88
Predicate Device(s)
LVivo IQS K222970
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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October 4, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size.
DiA Imaging Analysis Ltd. % George Hattub Medical Device Regulatory Affairs Specialist Medicsense USA LLC 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K240553
Trade/Device Name: LVivo Software Application Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: September 13, 2024 Received: September 13, 2024
Dear George Hattub:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Samuel Tike for
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
LVivo Software Application
Indications for Use (Describe)
L Vivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the alphanumeric string "K240553" in a simple, sans-serif font. The characters are black against a white background. The string appears to be a code or identifier, possibly a product or serial number.
510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | Submitter
Address: | George J. Hattub
Medicsense USA LLC
291 Hillside Avenue
Somerset, MA 02726
ghattub@comcast.net |
|--------|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer
Address: | DiA Imaging Analysis Ltd
HaEnergia Street 77
Beer-Sheva, Israel 8470912 |
| | Mfg. Phone: | Tel.: +972 77 7648318 |
| | Contact Person: | Mrs. Michal Yaacobi |
| | Date: | October 3, 2024 |
| 2. | Device &
Classification
Name: | Medical Image Management and Processing System -
classified as Class 2 QIH, Regulation Number 21 CFR 892.2050
LVivo Software Application |
| 3. | Predicate Devices: | LVivo IQS K222970 |
| 4. | Description: | The LVivo platform is a software system for automated analysis of
ultrasound examinations. Automated analysis of echocardiographic
examinations is done using DICOM movies. The LVivo platform supports
global and segmental evaluation of the left ventricle (LV) of the heart. The
global LV function is evaluated from two of the apical views: four-chamber
(4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LV
function is done from three apical views 4CH, 2CH and three chamber
(3CH) and supports wall motion evaluation and strain. The LVivo platform
supports also global and segmental evaluation of the LV from the
parasternal Short Axis (SAX) view and the Parasternal Long Axis view
(PLAX).
LVivo PLAX extends the current toolbox of the LVivo platform, providing
automated calculation of LV size and function parameters from the PLAX
view, for cardiac function evaluation as part of the standard echocardiographic
assessment in Echo environment and point-of-care. The measurements from
the PLAX view add information about the contraction of the LV, its size and
wall thickness and can be used for rapid evaluation of the patient's condition
in the point-of-care.
In addition to the LV analysis, the cardiology toolbox includes a module for
automated evaluation of the Right Ventricular function and the LVivo
Seamless. The LVivo platform includes one additional non-cardiac module
for the measurement of the bladder volume. |
5
- LVivo platform is intended for non-invasive processing of ultrasound 5. Indications for images to detect, measure, and calculate relevant medical parameters of Use: structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.
-
- Comparison of With respect to technology and intended use, DiA's LVivo Software Technological Application is substantially equivalent to its predicate devices. Based upon Characteristics: the outcomes from the risk analysis and Performance Testing Evaluation, DiA believes that the addition of LVivo PLAX module to the LVivo Software Application predicate device does not raise additional safety of efficacy concerns. The following comparison table depicts the changes.
| Submitted Device | Predicate Device | |
|---|---|---|
| Features/Characteristics | LVivo Software | |
| Application | LVivo IQS | |
| Product Code | same | QIH |
| Indication for Use | same | LVivo platform is |
| intended for non- | ||
| invasive processing | ||
| of ultrasound | ||
| images to detect, | ||
| measure, and | ||
| calculate relevant | ||
| medical parameters of | ||
| structures and | ||
| function of patients | ||
| with suspected | ||
| disease. In addition, it | ||
| has the ability to | ||
| provide Quality Score | ||
| feedback | ||
| Modules | LVivo PLAX, LVivo IQS, | |
| LVivo EF, LVivo SG, | ||
| LVivo SAX, LVivo RV, | ||
| LVivo Seamless & | ||
| LVivo Bladder | LVivo IQS, LVivo EF, | |
| LVivo SG, LVivo SAX, | ||
| LVivo RV, LVivo | ||
| Seamless and LVivo | ||
| Bladder | ||
| Automation | same | yes |
| Manual Adjustment | same | yes |
| Bi plane EF evaluation | same | yes |
| Simultaneous 2CH and | ||
| 4CH evaluation | same | yes |
| Off-line LV RV and | ||
| Bladder evaluation using | ||
| DICOM clips of any | ||
| vendor | same | yes |
| Automated ED and ES | ||
| frames selection | same | yes |
| Manual ED and ES frames | ||
| selection | Added for the PLAX | |
| view | no | |
| Dynamic left ventricular | same | yes |
| Manual editing by | ||
| user capability | same | yes |
| Visually confirm | ||
| results | same | yes |
| Automated rejection | ||
| of false results | same | yes |
| Volume calculation by | ||
| standard Simpson's | ||
| method of discs for EF | same | yes |
| Volume curve | ||
| Presentation | same | yes |
| EF, Strain, SWM, RV, | ||
| SAX, Bladder results | ||
| presentation | same | yes |
| Enables presentation of | ||
| cardiac function results | ||
| for different cycles | same | yes |
| Algorithm | Added Support | |
| for PLAX view | yes | |
| Calculation speed | same | yes |
| Capability or a part of a | ||
| bigger package (device) | ||
| for LV function | ||
| evaluation and Bladder | same | yes |
| Segmental Longitudinal | ||
| Strain Measure | same | yes |
| Global Longitudinal | ||
| Strain Measure | same | yes |
| Segmental wall motion | ||
| evaluation | same | yes |
| Operating System | Same | Windows/Linux |
| (with Android | ||
| option for LVivo | ||
| EF) | ||
| 510(k) # | Pending | K222970 |
6
7
7. Performance Evaluation:
A summary of the Performance Evaluation, which was based upon wellestablished test methods, demonstrated conformity to the intended use.
The clinical validation included a set of 121 patients referred for routine transthoracic echocardiography according to GCP standards. The population was comprised of 60% male, average age of 66.5 ±17. Inclusion criteria: Age ≥18. sinus rhythm without multiple premature beats. Patients with LBBB were excluded from the study. 49% had Normal global LV systolic function, 27% had dilated LV, 24% had LVH, 17% had CAD.
Acceptance criteria for Fractional Shortening (FS): correlation >=75% vs manual measurements.
Results
A total of 99 exams (82%) were automatically analyzed. The correlation vs average manual measurements of two sonographers was r=0.79, the primary end point was met. Specificity and sensitivity using cutoff value of 28% were 85% and 85% respectively.
Additional Dataset
An additional dataset, with exams collected from a USA based medical center, was used for LVivo PLAX validation. The data set included 40 patients with similar inclusion\exclusion criteria as described above. The patient population comprised 67.5% (27) male, average age was 60±14 ranging from 27 to 87 years of age. BMI measurement was available for 95% (38) of patients with an average BMI of 31.6± 9.1 ranging from 18.3 to 67.
16.67% (6) had normal systolic LV function, 25% (9) had a mildly impaired LV systolic function, 33.3% (12) were moderately impaired and additional 25% (9) were severely impaired. 25% (10) of patients had dilated LV size. 25% (10) have reported to have LV hypertrophy
The LVivo PLAX was applied automatically to the clips from the 40 exams. 90% of exams were automatically analyzed. Results acceptance considered bias and limits of agreement (LOA) as well as correlation for the calculated parameters. The results are provided below:
8
Results of Additional Dataset
| Measurements | Sonographers Agreement | LVivo PLAX vs Sonographers |
|---|---|---|
| LVIDd | Corr: 0.95 | Corr:0.9. |
| Bias: 0.12cm | Bias:0.3cm | |
| LOA: -0.71, 0.46 | LOA -0.2, 0.9 | |
| LVIDs | Corr: 0.94 | Corr:0.95. |
| Bias: -0.097cm | Bias:0.42cm | |
| LOA: -4.1, 3.9 | LOA -0.25, 1.1 | |
| FS | Corr: 0.79 | Corr:0.74*. |
| Bias: 1.75% | Bias:-4% | |
| LOA: -12.7, 16.2 | LOA -19.98, 11.96 | |
| IVSD | Corr: 0.86 | Corr:0.72. |
| Bias: -0.08 | Bias:-0.16cm | |
| LOA: -0.3, 0.17 | LOA -0.47, 0.13 | |
| PWD | Corr: 0.73 | Corr: 0.68. |
| Bias: 0.06cm | Bias:-0095cm | |
| LOA: -0.3, 0.4 | LOA -0.21, 0.4 | |
| LV Mass | Corr: 0.9 | Corr:0.94. |
| Bias: -10.43gr | Bias:9.14gr | |
| LOA: -88,68 | LOA -41.6, 59.88 |
- Conclusion: The intended use and the technological characteristics in the current device are the same as those in the predicate device. Likewise, the modifications do not affect the safety and effectiveness of the device. The performance tests have been completed and successfully verify the validated performance of the subject device. Therefore, DiA Imaging Analysis has concluded the LVivo Software Application is substantially equivalent to the predicate device.